there is more to clean environments than meets the eye ... · technical specifications for mas-100...

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There is more to clean environments than meets the eye Leading solutions for air monitoring The new MAS-100 Iso NT ®

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Page 1: There is more to clean environments than meets the eye ... · Technical specifications for MAS-100 Iso NT® Instrument Features Specifications Nominal airflow 100 SLPM ± 2.5 % (Standard

There is more to clean environments than meets the eye Leading solutions for air monitoring The new MAS-100 Iso NT®

Page 2: There is more to clean environments than meets the eye ... · Technical specifications for MAS-100 Iso NT® Instrument Features Specifications Nominal airflow 100 SLPM ± 2.5 % (Standard

Functional principle

The MAS-100 Iso NT® is a high-performance instrument that is based on the Anderson impaction principle. It directs the air flow onto a standard Petri dish containing agar medium. After the collection cycle, the Petri dish is incubated and the colonies counted.

MAS

-100

Iso

NT® Introduction

The MAS-100 Iso NT® is specially designed for monitoring microbiological contamination of the air in aseptic production areas and isolators with the rigorous requirements of the pharmaceutical industry in mind. A unique safety concept permits the installation of various sampling heads for standard 90 – 100 mm Petri dishes at the critical control points while all electronic and moving parts remain outside the critical zone. The MAS-100 Iso NT® has an advanced, integrated pump with flow control for automatic decontamination of the sampling head and the aspiration tube. The MAS-100 Iso NT® is built according to GAMP 4 and corresponds to the ISO 14698 standard. It is a completely validated system designed for the highest demands.

heipha® ICR and ICRplus Settle Plates

The heipha® ICR and ICRplus Settle Plates are produced under aseptic conditions, gamma-irradiated and triple-bagged, making them optimal for active air monitoring with MAS-100® Microbial Air Samplers. All of the MAS-100® Air Samplers have been validated according to ISO 14698 using heipha® ICR and ICRplus Settle Plates – they all showed the same reliable results in physical and biological efficiency testing.

Air exaust Decontaminant exaust

Page 3: There is more to clean environments than meets the eye ... · Technical specifications for MAS-100 Iso NT® Instrument Features Specifications Nominal airflow 100 SLPM ± 2.5 % (Standard

Key Features

• Integrated mass-flow sensor

• Easy network connection of up to 9 units via USB

• Inlet/outlet on the same side

• 360° rotatable display

• Stainless steel head available

• Software in several languages

• Double valve security system

• Active sampling flow control

• Active decontamination flow control

• Protected mode/user protection

• Alarm log file

• Sample log file

• IP54 model available

• 3/4 inch Tri-Clamp connection

Advantages

• Easy installation

• Easy software navigation

• Uses standard 90 – 100 mm Petri dishes

• GAMP 4 validated

• Hands free, in-line decontamination

• Based on established Andersen impaction principle

• Fully meets the new d50 regulation

• Fully compliant design according to ISO 14698 using heipha media

• Same collection principle and efficiency as all other MAS-100® instruments

Standard Design:

• Petri dish 90 – 100 mm, adjustable

• Horizontal and vertical flow

• Autoclavable

Easy Clean Design:

• Petri dish 90 – 100 mm, not adjustable

• Vertical flow only

• Autoclavable and easy cleaning, no dead spaces

MAS-100 Iso NT® Physical Efficiency110

82,5

55

27,5

00 1,5 3 4,5 6

Aver

age

% P

hysic

al E

fficie

ncy

Particle Size (Mass mean diameter, µm)

Page 4: There is more to clean environments than meets the eye ... · Technical specifications for MAS-100 Iso NT® Instrument Features Specifications Nominal airflow 100 SLPM ± 2.5 % (Standard

Technical specifications for MAS-100 Iso NT®Instrument Features Specifications

Nominal airflow 100 SLPM ± 2.5 % (Standard litres per minute on mass flow)Dimensions 16 x 28.3 x 23 cm (L/W/H)Weight* 7.5 kg without sampling headPower 110 – 240 V, 1.5 A, 50 – 60 HzPower input DC 24 V, 3.25 A, 65 W max.Max current 2.5 ADisplay Backlit liquid crystal displayPreset sampling volumes 100, 250, 500, 750 and 1,000 SLPMUser definable sampling volume range 1 to 2,000 SLPMMaterial Anodized aluminumValves Rigid PVC/Viton®/SSAnemometer Hot wire, numeric control

Alphanumeric liquid crystal display, 2 x 8 charactersHot-wire anemometer RTC (Real Time Clock) battery; lifetime of approx. 10 yearsGuidelines 73/23/EEC, 89/336/EEC, DIN EN 61326-1:1997,

DIN EN 61010-1:2001, GAMP 4.0:2001CE Approval EN 61000-4-2; EN 61000-4-4; EN 61000-4-5; EN 61000-4-11;

EN 61000-4-8; EN 61000-4-6; EN 61000-4-3

Technical specifications for MAS-100 Iso NT® Sampling HeadSampling Head Features Specifications*

Weight* 1.5 kgMaterial* 316L stainless steelConnector 3/4″ Tri-ClampDiameter 10.9 cmHeight 9 cm

Ordering information MAS-100 Iso NT®Description Catalog No.

MAS-100 Iso NT® control unit 1.09168.0001MAS-100 Iso NT® contol unit with Profibus 1.09173.0001MAS-100 Iso NT® contol unit with Ethernet 1.09174.0001

Ordering information Accessories MAS-100 Iso NT® product lineDescription Catalog No.

MAS-100 Iso NT® Perforrated lid, stainless steel, 300-hole edge protected 1.09189.0001MAS-100 Iso NT® Perforrated lid, stainless steel, 400-hole edge protected 1.09222.0001MAS-100 Iso NT® Base for Sampling Head, stainless with Tri-Clamp and gasket 1.09328.0001MAS-100 Iso NT® Perforated lid, stainless steel, 300-hole 1.09329.0001MAS-100 Iso NT® Perforated lid, stainless steel, 400-hole 1.09424.0001MAS-100 Iso NT® Tri-Clamp, stainless steel 1.09440.0001MAS-100 Iso NT® Dust Cover, stainless steel 1.09644.0001MAS-100 Iso NT® Power Supply 1.17182.0001MAS-100 Iso NT® Elbow Joint with 2 Tri-Clamps 1.17083.0001MAS-100 Iso NT® Silicone Gasket 1.17084.0001MAS-100 Iso NT® Pressure Test Kit 1.17085.0001MAS-100 Iso NT® Silicone gaskets for easy clean base 1.17099.0001MAS-100 Iso NT® Easy clean Base for sampling head, stainless steel, with 1 Tri-Clamp and 1 gasket

1.17091.0001

MAS-100 Iso NT® USB cable, 10 m 1.17098.0001MAS-100 Iso NT® IP54 kit 1.17159.00014” Opticap XL 4 KTGRA04TT35” Opticap XL 5 KTGRA05TT1

* dependent on material selected

Validation Protocol MAS-100 Iso NT®Description Catalog No.Validation Protocol MAS-100 Iso NT® MAISA4VP1

Page 5: There is more to clean environments than meets the eye ... · Technical specifications for MAS-100 Iso NT® Instrument Features Specifications Nominal airflow 100 SLPM ± 2.5 % (Standard

Related productsheipha® ICRplus Settle Plates (lockable) Package size Ord. No.

TSA + LTHTh - ICR+(Tryptic Soy Agar with neutralizers lecithin, Polysorbate (Tween®) 80, histidine and sodium thiosulfate)

20120

1.46683.0020 1.46683.0120

TSA + LT - ICR+ (Tryptic Soy Agar with neutralizers lecithin and Polysorbate (Tween®) 80)

20120

1.46684.00201.46684.0120

TSA - ICR+ (Tryptic Soy Agar)

20120

1.46685.00201.46685.0120

Chocolate Agar + LTH - ICR+ (Chocolate Agar with neutralizers lecithin, Polysorbate (Tween®) 80 and histidine)

20 1.46686.0020

heipha® ICR Settle Plates (triple-bagged, gamma-irradiated, non-lockable) Package size Ord. No.

Sabouraud Dextrose Agar - ICR 20120

1.46577.0020 1.46577.0120

Sabouraud Dextrose Agar + LT - ICR(SDA with lecithin and Polysorbate (Tween®) 80)

20120

1.46081.00201.46081.0120

Sabouraud Dextrose Agar + LTHTh - ICR 30 ml(SDA with lecithin, Polysorbate (Tween®) 80, histidine and thiosulfate)

20120

1.46005.00201.46005.0120

Sabouraud Dextrose Agar selective + LTHTh - ICR (SDA with lecithin, Polysorbate (Tween®) 80, histidine and thiosulfate and irradiation-resistant antibiotics for growth inhibition of accompanying bacterial flora)

20120

1.46016.00201.46016.0120

Tryptic Soy Agar - ICR 20120

1.46001.00201.46001.0120

Tryptic Soy Agar + LT - ICR (TSA with lecithin and Polysorbate (Tween®) 80)

20120

1.46050.00201.46050.0120

Tryptic Soy Agar + LTHTh - ICR (TSA with lecithin, Polysorbate (Tween®) 80, histidine and thiosulfate)

20120

1.46069.00201.46069.0120

Tryptic Soy Agar + LT + Cephase - ICR (TSA with lecithin and Polysorbate (Tween®) 80 and specific beta-lactamase mixture for inactivation of a broad spectrum of penicillins, cephalosporins and carbapenems)

20120

1.46076.00201.46076.0120

Tryptic Soy Agar + LTHTh + Penase - ICR (TSA with lecithin, Polysorbate (Tween®) 80, histidine, thiosulfate and beta-lactamase for inactivation of penicillins)

20120

1.46013.00201.46013.0120

Vegetable Peptone Agar + LTHTh - ICR (PSA (caseine peptone replaced by vegetable peptone) with lecithin, Polysorbate (Tween®) 80, histidine and thiosulfate)

20120

1.46658.00201.46658.0120

Find more information regarding the MAS-100® Family in the family brochure.

Page 6: There is more to clean environments than meets the eye ... · Technical specifications for MAS-100 Iso NT® Instrument Features Specifications Nominal airflow 100 SLPM ± 2.5 % (Standard

Merck KGaAFrankfurter Straße 25064293 Darmstadt, Germanye-mail: [email protected]/biomonitoring

Merck, Merck Millipore and the M logo are registered trademarks of Merck KGaA, Darmstadt, Germany. MAS-100 Iso NT® is registered trademark of MBV, Staefa, Switzerland.All other trademarks are the property of their respective owners.Lit No. DS5770EN00 03/2015© 2015 Merck KGaA, Darmstadt, Germany. All rights reserved.

To Place an Order or Receive Technical AssistanceFind contact information for your country at: www.merckmillipore.com/offices

For Technical Service, please visit: www.merckmillipore.com/techservice

Related Services• Validation ProtocolsSave precious time with our comprehensive and regulations compliant validation protocols from validation master plan to final report.

• IQ/OQ ServicesSimplify the execution of your IQ/OQ. Our highly trained validation engineers will execute the Air Sampler validation protocol for you, in your lab.

• Service agreementsStay compliant and ensure reliability of your Air Sampler over time with our service agreements. Our service agreements include a yearly preventative maintenance, a new calibration certificate, and a performance report as well as extended warranty options. Our highly trained service engineers can come into your lab to service your Air Sampler.Not available in all areas

Please contact your local sales representative for more information or a quotation.

We provide information and advice to our customers on application technologies and regulatory matters to the best of our knowledge and ability, but without obligation or liability. Existing laws and regulations are to be observed in all cases by our customers. This also applies in respect to any rights of third parties. Our information and advice do not relieve our customers of their own responsibility for checking the suita-bility of our products for the envisaged purpose.